Hello WBubel
Good document!
But i think you really tried to make a guide to a risk management file, not to a risk management report. I´m saying this because you seem to mix the concepts in the document. For example, the POTENTIAL FAILURE, CAUSE OF
FAILURE, EFFECTS OF FAILURE, RESPONSE, RISK INDEX and ACTION TAKEN applies to hazardous situations, not to hazards... hazards are the general "problem", and the hazardous situations are the ways in which the problem can come to pass.
For example:
Patient leakage current is an energy hazard. Thare are X situations in which a potential failure (for example in a component) caused by, for example a wrong line voltage, can lead to a hazardous situation of a patient being exposed to a source of leakage current, which could lead to harm (effects, for example, shock or burn). If the risk of the hazardous situation (potential failure + potential situation + effects) is unacceptable, you have to control the risk (response - for example, limiting the impedance) taking an action, and after that verify that the risk is acceptable (risk index?).
This is the general proccess which have to be performed and recorded in the risk management file. The risk management report, on the other hand, is a summary of the risk management file (the stadard has been revised to remove the traceability requirement on the report because the sizae of reposrt, when you put all the hazardous situations - which are many many many - was too big, which was not the intention of the original requirement).
So, in my opinion, you shoul remove the POTENTIAL FAILURE, CAUSE OF
FAILURE and EFFECTS OF FAILURE (and page 3 too!) as they are not applied to the hazards described. Besides that, you doc lacks the information on implementation of the risk management plan, and the information about methods of obtaining production and post-production information (i´m assuming the RISK INDEX is the acceptable risk defined by the policy of 3.2 a), but i think you´ll have to explicit it better anyway - what you could to is to put a column on "overrall residual risk", and then compare it with the risk index.
Cheers!
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